Table 1

Schedule of enrolment, interventions and assessments

Study period
Enrolment (screening)Allocation
(baseline)
TreatmentFollow-up (endpoint)
Time pointWeek −4Week −1Week 0Week 1Week 12Week 13Week 24
Enrolment
  Eligibility screen ×
  Informed consent ×
  Allocation ×
Interventions
  Treatment group Embedded Image
  Control group Embedded Image
Assessments
  Headache diary Embedded Image Embedded Image
  MIDAS × × ×
  MSQ × × ×
  HIT-6 × × ×
  STAI-T × × ×
  BDI-II × × ×
  Blinding/credibility test × ×
  Adverse event Embedded Image Embedded Image
  Laboratory test* × × ×
  • *The laboratory test includes complete blood count and differential count, absolute neutrophil count, aspartate aminotransferase, alanine aminotransferase, total bilirubin, blood urea nitrogen, creatinine, albumin and coagulation test.

  • BDI-II, Beck Depression Inventory-II; HIT-6, Headache Impact Test; MIDAS, Migraine Disability Assessment; MSQ, Migraine-Specific Quality of Life Questionnaire; STAI-T, State-Trait Anxiety Inventory-trait.